Breast CancerPhase 2NCT00270491
Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.
A Phase 2 study testing Paclitaxel and Capecitabine in people with Breast Cancer and Neoplasm Metastasis, run by ARCAGY/ GINECO GROUP at 1 site in France.
Trial summary
Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neoplasm Metastasis
- What is being tested?
- Paclitaxel and Capecitabine
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2005to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Femal patient aged > 18 years
- Histologically proven breast adenocarcinoma
- HER2 negative receptors
- previously received first or second line chemotherapy for metastatic disease
- previously treated with anthracycline and/or docetaxel in adjuvant and/or as first or second line therapy
- presence of one or several evaluable metastatic lesion(s)
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- presence of at least one target lesion not previously irradiated
- previously treated with hormonotherapy in adjuvant or in metastatic line (treatment will be ceased upon patient registration in the study)
- ECOG Performance status < 2
- adequate biological values
- patient who has clearly given her consent by signing on informed consent form prior to participation
Who cannot join
- patient previously treated with paclitaxel or capecitabine for metastatic breast cancer
- patient with only local metastatic disease (with the exception of axillary lymph nodes)
- active symptomatic brain metastasis
- patient with an history of significant cardiovascular impairment (congestive heart failure> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
- peripheric neuropathy grade ≥ 2
- history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin)
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- patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
- patient with a known allergy to one or several of the study compounds
- patients who may not be regularly available due to geographical, social or family reasons
- history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
- deficiencies of the upper intestinal tract, malabsorption syndrome
- patient who is pregnant, breast-feeding or using inadequate contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer.
Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.
Read the detailed description
The purpose of this study is to know if we can optimize in term of tolerance even of efficacy the plan of administration of weekly paclitaxel associated with capecitabine.
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Being tested
- Paclitaxel, Capecitabine
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
CapecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerance of the patients in the both groups.
Secondary outcomes (4)
- Response rates and duration of response.
- Haematological and non-haematological toxicities.
- Progression free survival.
- Overall survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Investigators
- Rémy LARGILLIER, Physician, Principal investigator, Centre ANTOINE LACASSAGNE - NICE (FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270491
- Sponsor's protocol ID
- TAXEL
- Status last verified
- Feb 2011
- First submitted
- 26 Dec 2005
- Last updated
- 25 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT00270491
- Acronym / sponsor ID
- TAXEL
- Conditions
- Breast Cancer, Neoplasm Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.
Detailed description
The purpose of this study is to know if we can optimize in term of tolerance even of efficacy the plan of administration of weekly paclitaxel associated with capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Femal patient aged > 18 years
- Histologically proven breast adenocarcinoma
- HER2 negative receptors
- previously received first or second line chemotherapy for metastatic disease
- previously treated with anthracycline and/or docetaxel in adjuvant and/or as first or second line therapy
Key exclusion criteria (12 listed)
- patient previously treated with paclitaxel or capecitabine for metastatic breast cancer
- patient with only local metastatic disease (with the exception of axillary lymph nodes)
- active symptomatic brain metastasis
- patient with an history of significant cardiovascular impairment (congestive heart failure> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
- peripheric neuropathy grade ≥ 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel | Drug | – |
| Capecitabine | Drug | – |
Primary outcome
tolerance of the patients in the both groups.
4 secondary outcomes
- Response rates and duration of response.
- Haematological and non-haematological toxicities.
- Progression free survival.
- Overall survival.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémy LARGILLIER, Physician principal investigator
Centre ANTOINE LACASSAGNE - NICE (FRANCE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Capecitabine in people with Breast Cancer and Neoplasm Metastasis, run by ARCAGY/ GINECO GROUP at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tolerance of the patients in the both groups.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2011.